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Lucemyra Web Site Home Page False or Misleading: FDA

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FDA cautions BioCorRx about false and misleading information on the Web site home page for its Lucemyra.

Vanda Blasts FDA Plan to Lengthen Drug Review Times

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Vanda Pharmaceuticals says FDA should withdraw a legislative proposal in its budget package that the company says would lengthen N...

FDA, Device Industry Reach Agreement on MDUFA VI

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FDA and the device industry are nearing a final agreement on the next round of Medical Device User Fee Act (MDUFA VI) negotiations...

Medline Class 1 Recall of Angiographic Control Syringes

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Medline Industries recalls (Class 1) its angiographic control syringes, warning the devices could cause severe injury or death.

FDA Lifts Partial Clinical Hold on MacroGenics Cancer Study

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FDA removes partial clinical hold against MacroGenics Phase 2 LINNET study evaluating the investigational cancer therapy lorigerli...

Mass Compounding Threatens FDA Enforcement: Column

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An FDA Matters column calls on FDA to fully enforce the laws against mass compounding of approved drugs that are not in shortage.

FDA Budget Proposal Signals Push for Tighter Ad Oversight

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Law firm Sheppard breaks down some of FDAs proposals in its budget documents that industry should keep a close eye on, including n...

Workshop on Novel Surrogate Endpoints for Rare Disease Drugs

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FDA announces a 5/18 virtual public workshop aimed at advancing the use of novel surrogate endpoints in developing treatments for ...

Insmed Halts Brensocatib Program After Mid-Stage Trial Miss

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Insmed discontinues development of its drug candidate brensocatib for hidradenitis suppurativa after a mid-stage clinical trial fa...

See Supply Chain Strategy as Core Regulatory Function: Attorney

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Baker Hostetler attorney Winston Kirton says life sciences companies that are active in both the U.S. and the EU need to change th...